Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma
Фаза 3 – широко изпитване преди одобрение
Заболявания:
Follicular Lymphoma (FL)
Спонсор: Genmab
Налично на:
БГ
Обобщение
Follicular Lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with relapsed or refractory (R/R) FL. Adverse events and change in disease condition will be assessed.
Epcoritamab is an investigational drug being developed for the treatment of FL. Study doctors put the participants in 1 of 3 groups, called treatment arms. Each group receives a different treatment. Enrollment to one of the groups is closed. Around 500 adult participants with R/R FL will be enrolled in approximately 300 sites across the world.
Participants will receive R2 (375 mg/m\^2 intravenous infusion of rituximab up to 5 cycles and oral capsules of 20 mg lenalidomide for up to 12 cycles) alone or in combination with subcutaneous injections of epcoritamab for up to 12 cycles (each cycle is 28 days).
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Кой може да участва
Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2.
* Participant has:
* Fluorodeoxyglucose-positron emission tomography (FDG-PET) scan demonstrating positive lesion compatible with computed tomography (CT) or magnetic resonance image (MRI)-defined anatomical tumor sites AND
* \>= 1 measurable nodal lesion (long axis \> 1.5 cm) or \>= 1 measurable extra-nodal lesion (long axis \> 1.0 cm) on CT scan or MRI.
* Histologically confirmed classic follicular lymphoma (FL) \[previously Grade 1 to 3a FL\] stage II, III, or IV with no evidence of histologic transformation to an aggressive lymphoma and CD20+ disease on most recent representative tumor biopsy based on the pathology report.
* Relapsed or refractory (R/R) disease to at least one prior systemic regimen that contained an anti-CD20 monoclonal antibody (mAb) in combination with chemotherapy. (Participant who received only prior anti-CD20 mAb monotherapy and/or radiation therapy is not eligible.)
* Eligible to receive R2 per investigator determination.
* Estimated Creatinine Clearance (CrCl) \>= 50 mL/min.
Exclusion Criteria:
* Documented refractoriness to lenalidomide.
* Have lenalidomide exposure within 12 months prior to randomization.
Места на провеждане
27
Argentina (1)
Fundaleu /Id# 229700
Ciudad Autonoma de Buenos Aire , Buenos Aires F.D.
Австралия (1)
Royal Prince Alfred Hospital /ID# 239272
Camperdown , New South Wales
Белгия (1)
Uza /Id# 228521
Edegem , Antwerpen
Бразилия (1)
Hospital de Clinicas da Universidade Federal do Parana /ID# 228123
Curitiba , Paraná
Канада (1)
Cross Cancer Institute /ID# 249080
Edmonton , Alberta
Китай (1)
Peking University First Hospital /ID# 250517
Beijing , Beijing Municipality
Чехия (1)
Fakultní nemocnice Hradec Králové - Sokolská /ID# 228269
Hradec Králové , Hradec Kralove
Дания (1)
Regionshospitalet Godstrup /ID# 227466
Herning , Central Jutland
Франция (1)
CHU Clermont-Ferrand /ID# 238676
Clermont , Auvergne-Rhône-Alpes
Гърция (1)
General Hospital of Athens Laiko /ID# 226626
Athens , Attica
Унгария (1)
Semmelweis Egyetem /ID# 229291
Budapest , Budapest
Израел (1)
Yitzhak Shamir Medical Center /ID# 228037
Ẕerifin , Central District
Италия (1)
Azienda Ospedaliero - Universitaria SS. Antonio e Biagio e Cesare Arrigo - Aless /ID# 227401
Alessandria , Alessandria
Япония (1)
Duplicate_NHO Nagoya Medical Center /ID# 230678
Nagoya , Aichi-ken
Нидерландия (1)
Canisius-Wilhelmina Ziekenhuis /ID# 248138
Nijmegen , Gelderland
New Zealand (1)
Aotearoa Clinical Trials /ID# 228509
Papatoetoe , Auckland
Полша (1)
ARS-MEDICAL Sp. z o.o. /ID# 229601
Piła , Greater Poland Voivodeship
Puerto Rico (1)
Hematology and Oncology Institute /ID# 230056
Manati , Puerto Rico
Словакия (1)
Narodny onkologicky ustav /ID# 239510
Bratislava , Bratislava Region
South Africa (1)
Wits Clinical Research /ID# 228895
Johannesburg , Gauteng
Южна Корея (1)
Inje University - Busan Paik Hospital /ID# 230293
Busan , Busan Gwang Yeogsi
Испания (1)
Instituto Catalan de Oncologia (ICO) Badalona /ID# 228108
Badalona , Barcelona
Швеция (1)
Sunderby sjukhus /ID# 228165
Luleå , Norrbotten County
Taiwan (1)
Kaohsiung Chang Gung Memorial Hospital /ID# 227384
Kaohsiung City , Kaohsiung
Турция (1)
Ankara Universitesi Fakultesi /ID# 227790
Ankara , Ankara
Великобритания (1)
University Hospitals Birmingham NHS Foundation Trust /ID# 230043
Birmingham , Birmingham
САЩ (1)
The University of Arizona Cancer Center - North Campus /ID# 228862